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Antibiotics after gallbladder surgery may be unnecessary

NCT ID NCT01015417

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at whether giving antibiotics after gallbladder removal surgery helps prevent infections in people with mild to moderate gallbladder inflammation. Over 400 adults took part, receiving either antibiotics or no medication after surgery. The goal was to see if antibiotics reduce surgical site or other infections within 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
amoxicillin clavulanic acid (Augmentin)
What this could lead to
If successful, this could show that antibiotics after gallbladder surgery are not needed for mild to moderate cases, reducing side effects and antibiotic resistance.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to severe cases or patients with complications. The benefit of antibiotics may be small or absent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

414 people

The number who actually took part.

Start date

May 2010

Finished

Nov 2012

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Acute lithiasic cholecystitis low or moderately severe (confined to the gall bladder) * Requiring early cholecystectomy (progression of symptoms \<5 days * In an adult patient (\>18 years) * For each patient included the consent form must have been read, understood and signed. Exclusion Criteria: * Severe acute cholecystitis (with organ dysfunction) * Acalculous cholecystitis * Biliary peritonitis * Abscess perivesicular * Cholangitis * Acute Pancreatitis * Septic shock * Stone of bile duct * Physical or mental state does not allow participation in the study * Contraindication to surgery * Classification ASA (American Society of Anesthesiologists) IV-V or life expectancy \<48 hours * Suspected pre-or intraoperative cancer of the gallbladder * Pregnancy or breastfeeding * Treatment course with methotrexate, imidazole * Known history of allergy to Augmentin ®

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Conditions

The condition(s) this trial relates to.

acute cholecystitis Surgical Wound Infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Centre Hopitalier Général

    Grenoble, Auvergne-Rhône-Alpes, 38700, France

  • Centre Hospitalier

    Longjumeau, Ile de Rance, 91161, France

  • Centre Hospitalier C.H.A.M.

    Rang-du-Fliers, Hauts-de-France, 62180, France

  • Centre Hospitalier Cochin

    Paris, Île-de-France Region, 75679, France

  • Centre Hospitalier Côte e Nacre

    Caen, Basse Normandie, 14033, France

  • Centre Hospitalier Dupuytren

    Limoges, Limousin, 87042, France

  • Centre Hospitalier Haut-Lévêque

    Bordeaux, Aquitaine, 33604, France

  • Centre Hospitalier Jean-Verdier

    Bondy, Île-de-France Region, 93143, France

  • Centre Hospitalier Louis Mourier

    Colombes, Île-de-France Region, 92700, France

  • Centre Hospitalier Timone

    Marseille, Province-Alpes Côte d'Azur, 13000, France

  • Centre Hospitalier de Saint-Germain en Laye

    Poissy, Île-de-France Region, 78303, France

  • Centre de Chirurgie Viscérale et de Transplantation Centre Hospitalier Régional Universitaire

    Strasbourg, Alsace, 67098, France

  • Centre hospitalier Lariboisière

    Paris, Île-de-France Region, 75475, France

  • Centre hospitalier Universitaire

    Angers, Pays de la Loire Region, 49933, France

  • Chirurgie Viscérale et Digestive

    Rouen, Seine Maritime, 76031, France

  • Chirurgie viscérale et urologique Centre Hospitalier

    Beauvais, Oise, 60021, France

  • Service de Chirurgie Digestive et Vasculaire. Centre Hopsitalier Universitaire

    Besançon, Doubs, 25030, France

  • Service de Chirurgie Digestive et Viscérale

    Paris, Île-de-France Region, 75020, France

  • Service de Chirurgie Digetsive Centre Hopsitalier Universitaire

    Montpellier, Hérault, 34000, France

  • Service de Chirurgie Générale et Digestive. Centre Hospitalier Universitaire

    Clermont-Ferrand, Auvergne, 63003, France

  • Service de Chirurgie Viscérale et Digestive

    Amiens, Picardie, 80054, France